DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 and 2 is/are amended. Claim 21 is canceled. Claims 1-20 are now pending examination.
Response to Arguments
Applicant’s arguments, filed 6/23/2026, with respect to the rejection(s) of claim(s) 1 and 2 under U.S.C. 102 have been fully considered and are persuasive. Examiner agrees the newly added limitations of “magnetic poles arranged along the elongate shaft in a field- shaping array that urges a ferrous needle into a predetermined position and alignment relative to the elongate shaft to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle relative to the elongate shaft” overcome the previous rejections as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Molmenti in view of Vleugels.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Molmenti et al. (US 20200069305 A1) (noted on IDS) in view of Vleugels et al. (US 20220008094 A1) (previously of record).
Regarding claim 1, Molmenti discloses a needle driver (1) for a winding technique of intracorporeal suture tying (Paragraph 0092 states “In exemplary embodiments in which the knot tying device 1 is made up of more than one component, each component may be interchangeable with a corresponding component on another knot tying device”, thus any features disclosed as part of an alternative or exemplary embodiment are considered as interchangeable with the knot tying device 1), the needle driver comprising:
an elongate shaft (1100) having a proximal section (10), a distal section (20) (Figure 1, 26-27; Paragraph 0007; 0083), and
a handle assembly (handle) coupled to the proximal section of the elongate shaft (Figure 13; Paragraph 0132; 0140);
a clamp (jaws; 210+220) at the distal section of the elongate shaft, the clamp in mechanical communication with the handle assembly and the clamp including a first jaw and a second jaw configured to grasp a suture by moving relative to one another via actuation of the handle assembly to open and close the clamp (Figure 14-15, 26; Paragraph 0134);
a magnet section (1010) coupled to the elongate shaft between the proximal section and the distal section, the magnet section including a number of magnets creating a magnetic field shaped to orient a ferrous needle coupled to the suture in a predetermined alignment relative to the elongate shaft (Figure 26, 30; Paragraph 0172-173; 0184) (the magnets are placed on an exterior of a sheath, and shaped much like the magnets of the disclosed invention, thus are fully capable of being able to create a magnetic field shaped to orient a ferrous needle coupled to the suture in a predetermined position and alignment relative to the elongate shaft to repeatably and controllably orient an end portion of the suture, as there is no structure preventing such a function. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.); and
an actuator (trigger) coupled to the proximal section of the elongate shaft (Figure 5; Paragraph 0125; 0191; 0244), the actuator activatable with a trigger in the handle assembly to rotate the magnet section including the number of magnets about an axis of the elongate shaft relative to the clamp while maintaining a fixed axial spacing of the magnet section relative to the clamp (Paragraph 0013; 0069; 0124; 0132; 0244) (Molmenti discloses the sheath can be moved by activation mechanism with at least one of linear or rotational movement relative to the surgical instrument, thus the magnets on the sheath would be rotated while maintaining fixed axial spacing if the sheath is not moving linearly. Paragraph 0091 states the knot typing device 1, which is an elongated sheath is rotated. Paragraph 0126 discloses a trigger, which can be used to actuate and thus, rotate the sheath. Further, the magnets 1010 are located on the exterior of the sheath, thus as the sheath rotates, the magnets will also rotate.).
Molmenti fails to explicitly disclose the number of magnets with magnetic poles arranged along the elongate shaft in a field- shaping array that urges a ferrous needle into a predetermined position and alignment relative to the elongate shaft to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle relative to the elongate shaft.
However, Vleugels is directed to a magnetic surgical device and teaches a number of magents (82-87) arranged in a Halbach array (Paragraph 0129-130). As a result of the modification, the device of Molmenti with the array of Vleugels would be fully capable of urging a ferrous needle into a predetermined position and alignment relative to the elongate shaft as the Halbach array would orient the magnets into a predetermined position and align the needle accordingly, which could be done to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle relative to the elongate shaft.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Molmenti such that to include magnets arranged in a Halbach array, as taught by Vleugels as both references and the claimed invention are directed to magnetic surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Molmenti with the teachings of Vleugels by incorporating magnets arranged in a Halbach array in order to optimize the magnetic field (Vleugels Paragraph 0067).
Regarding claim 2, Molmenti discloses a needle driver (1) for a winding technique of intracorporeal suture tying (Paragraph 0092 states “In exemplary embodiments in which the knot tying device 1 is made up of more than one component, each component may be interchangeable with a corresponding component on another knot tying device”, thus any features disclosed as part of an alternative or exemplary embodiment are considered as interchangeable with the knot tying device 1),
the needle driver comprising:
an elongate shaft (1100) having a proximal section (10), a distal section (20) (Figure 1, 26-27; Paragraph 0007; 0083), and
a magnet section (1010) between the proximal section and the distal section, the magnet section including a number of magnet configured to orient a ferrous needle in a predetermined position and alignment relative to the elongate shaft to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle (the magnets are placed on an exterior of a sheath, and shaped much like the magnets of the disclosed invention, thus are fully capable of being configured to orient a ferrous needle in a predetermined position and alignment relative to the elongate shaft to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle, as there is no structure preventing such a function. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.);); (Figure 26, 30; Paragraph 0172-173; 0184);
a handle assembly (handle) coupled to the proximal section of the elongate shaft (Figure 13; Paragraph 0132; 0140);
a clamp (jaws; 210+220) distal to the magnet section and coupled to the distal section of the elongate shaft, the clamp in mechanical communication with the handle assembly, and the clamp movable, via actuation of the handle assembly, between an open position and a closed position (Figure 14-15, 26; Paragraph 0134); and
an actuator (flange or trigger) coupled to the proximal section of the elongate shaft, the actuator activatable to rotate the magnet section including the number of magnets about an axis of the elongate shaft relative to the clamp while maintaining a fixed axial spacing of the magnet section relative to the clamp (Molmenti discloses the sheath can be moved by activation mechanism with at least one of linear or rotational movement relative to the surgical instrument, thus the magnets on the sheath would be rotated while maintaining fixed axial spacing if the sheath is not moving linearly.) (Paragraph 0013; 0069; 0124-125; 0132; 0191; 0244).
Molmenti fails to explicitly disclose the number of magnets with magnetic poles arranged along the elongate shaft in a field- shaping array that urges a ferrous needle into a predetermined position and alignment relative to the elongate shaft to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle relative to the elongate shaft.
However, Vleugels is directed to a magnetic surgical device and teaches a number of magents (82-87) arranged in a Halbach array (Paragraph 0129-130). As a result of the modification, the device of Molmenti with the array of Vleugels would be fully capable of urging a ferrous needle into a predetermined position and alignment relative to the elongate shaft as the Halbach array would orient the magnets into a predetermined position and align the needle accordingly, which could be done to repeatably and controllably orient an end portion of a suture swaged to the ferrous needle relative to the elongate shaft.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Molmenti such that to include magnets arranged in a Halbach array, as taught by Vleugels as both references and the claimed invention are directed to magnetic surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Molmenti with the teachings of Vleugels by incorporating magnets arranged in a Halbach array in order to optimize the magnetic field (Vleugels Paragraph 0067).
Regarding claim 3, Molmenti further discloses wherein the actuator includes a trigger actuatable to rotate the magnet section of the elongate shaft relative to the clamp about a longitudinal axis defined by the elongate shaft (Figure 3A-F; Paragraph 0091; 0125-26). (Paragraph 0091 states the knot typing device 1, which is an elongated sheath is rotated. Paragraph 0126 discloses a trigger, which can be used to actuate and thus, rotate the sheath. Further, the magnets 1010 are located on the exterior of the sheath, thus as the sheath rotates, the magnets will also rotate.)
Regarding claim 4, Molmenti further discloses wherein the actuator includes a knob (flange/protruding elements), and wherein predetermined rotation of the knob causes a corresponding rotation of the magnet section of the elongate shaft relative to the clamp about a longitudinal axis defined by the elongate shaft (Figure 4A; Paragraph 0091; 0124) (Paragraph 0091 states the knot typing device 1, which is an elongated sheath is rotated; the magnets 1010 are located on the exterior of the sheath, thus as the sheath rotates, the magnets will also rotate correspondingly.).
Regarding claim 5, Molmenti further discloses wherein spacing between the magnet section and the clamp remains constant, along a longitudinal axis defined by the elongate shaft, as the magnet section rotates about the longitudinal axis (the magnets are fixed on the shaft, thus the spacing remains constant) (Figure 26; Paragraph 0173).
Regarding claim 6, Molmenti further discloses wherein the proximal section of the elongate shaft rotates along with the magnet section of the elongate shaft as the magnet section rotates about a longitudinal axis defined by the elongate shaft (the magnets are fixed on the shaft thus the magnetic section rotates simultaneously with the rest of the shaft) (Figure 26; Paragraph 0173).
Regarding claim 7, Molmenti further discloses wherein the distal section of the elongate shaft is non-magnetic along at least an interface between the distal section and the magnet section (Molmenti discloses at least a portion of the sheath is made of an elastic material, or from a material in a list of materials including non-magnetic materials, thus the shaft can be non-magnetic in areas the magnets 1010 are not placed) (Figure 26; Paragraph 0011-12).
Regarding claim 9, Molmenti further discloses wherein the magnet section is rotatable at least 180 degrees in a first direction about a longitudinal axis defined by the elongate shaft (Paragraph 0069; 0122; 0234).
Regarding claim 10, Molmenti further discloses wherein the magnet section is rotatable at least 180 degrees in a second direction about the longitudinal axis, the second direction opposite the first direction (the shaft can be rotated both clockwise and counterclockwise, thus is rotatable in a first direction and a second direction) (Paragraph 0069; 0122; 0234).
Regarding claim 11, Molmenti further discloses wherein the magnet section extends circumferentially about a longitudinal axis defined by the elongate shaft (Figure 26; Paragraph 0174).
Regarding claim 12, Molmenti further discloses wherein the magnet section includes a plurality of magnets (Figure 26; Paragraph 0173).
Regarding claim 13, Molmenti as modified by Vleugels discloses the needle driver of claim 12, and Vleugels teaches an arrangement of a plurality of magnets includes a Halbach array (Paragraph 0130).
Regarding claim 14, Molmenti further discloses wherein the clamp is stationary as the magnet section of the elongate shaft rotates relative to the clamp about a longitudinal axis defined by the elongate shaft (Paragraph 0172 states “a magnetic/electromagnetic component that can be an instrument by itself (e.g., the magnetic element and instrument form a unitary structure), part of an instrument, or placed over any laparoscopic/robotic instruments (such as a sheath placed over graspers, needle drivers, dissectors, etc.)”, thus if the magnets are on a separate sheath which is rotated independently of the instrument with the jaws, the jaws would be stationary.) (Paragraph 0015; 0019; 0172-173)
Regarding claim 15, Molmenti further discloses wherein the clamp includes a first jaw and a second jaw, the first jaw and the second jaw movable relative to one another via actuation of the handle assembly to move the clamp between the open position and the closed position (Figure 14-15; Paragraph 0134).
Regarding claim 16, Molmenti further discloses wherein the clamp, the distal section of the elongate shaft, and the magnet section of the elongate shaft are sized to be movable to a treatment site through a port having a diameter greater than about 3 mm and less than about 12 mm (Paragraph 0074; 0089) (Molmenti discloses the device can be of various diameters and sizes to be adapt to instruments of various shapes and sizes and be used in a variety of procedures, thus the device of Molmenti is fully capable of being configured to fit through a port having a diameter between 3 mm and 12 mm).
Regarding claim 17, Molmenti further discloses wherein the handle assembly and the actuator are positioned relative to one another such that the handle assembly and the actuator are each independently actuatable by a user grasping the handle assembly using a neutral grip (Paragraph 0132, FIGs 11-13).
Regarding claim 18, Molmenti further discloses a rod (550) extending parallel to a longitudinal axis defined by the elongate shaft, wherein the clamp is coupled to the handle assembly via the rod, the handle assembly is actuatable to move the rod, and movement of the rod moves the clamp between the open position and the closed position (Figure 20A-C; Paragraph 0161). (Paragraph 0092 states “In exemplary embodiments in which the knot tying device 1 is made up of more than one component, each component may be interchangeable with a corresponding component on another knot tying device”, thus any features disclosed as part of an alternative or exemplary embodiment are considered as interchangeable with the knot tying device 1).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Molmenti in view of Vleugels as applied to claim 2 above and further in view of Bonutti (US 20030105474 A1) (previously of record).
Regarding claim 8, Molmenti as modified by Vleugels discloses the needle driver of claim 2, and further discloses the magnet section may comprise permanent magnets (Paragraph 0173) but fails to explicitly disclose wherein the magnet section includes one or more magnetized ferromagnetic materials.
However, Bonutti is directed to a magnetic suturing device and teaches permanent magnets include one or more magnetized ferromagnetic materials (Paragraph 0040).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Molmenti as modified by Vleugels such that the magnet section includes one or more magnetized ferromagnetic materials, as taught by Bonutti, as both references and the claimed invention are directed to suturing devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Molmenti as modified by Vleugels with the teachings of Bonutti by incorporating the magnet section includes one or more magnetized ferromagnetic materials as it is known that permanent magnets include ferromagnetic materials.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Molmenti in view of Vleugels as applied to claim 2 above, and further in view of Kogasaka et al. (US 5643293 A) (noted on IDS).
Regarding claims 19-20, Molmenti as modified by Vleugels discloses the needle driver of claim 2, but fails to further disclose a shaft feature operable with the magnet section to secure a needle along the distal section of the elongate shaft in a predetermined manner, wherein the shaft feature defines a channel structurally configured to receive at least a portion of the needle.
However, Kogasaka is directed to a suturing instrument and discloses a shaft feature (461A-D) operable with the magnet section (462A-D) to secure a needle (413) along the distal section of the elongate shaft (403) in a predetermined manner, wherein the shaft feature defines a channel structurally configured to receive at least a portion of the needle (Figure 102-103; Col 45, line 7-16).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Molmenti as modified by Vleugels to include a shaft feature operable with the magnet section to secure a needle along the distal section of the elongate shaft in a predetermined manner, wherein the shaft feature defines a channel structurally configured to receive at least a portion of the needle, as taught by Kogasaka, as both references and the claimed invention are directed to suturing devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Molmenti as modified by Vleugels with the teachings of Kogasaka by incorporating a shaft feature operable with the magnet section to secure a needle along the distal section of the elongate shaft in a predetermined manner, wherein the shaft feature defines a channel structurally configured to receive at least a portion of the needle in order to support and hold the needles.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
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